Ongoing Clinical Trials at Vedic

Health Condition: Osteoarthritis

Sponsor Location: Hong Kong

Study: An exploratory, randomized, controlled, crossover study to investigate the efficacy and tolerability of the novel investigational product in patients with pain in the knee joint due to mild and moderate Osteoarthritis

Status: Study Start up Phase

Health Condition: Blood Circulation

Sponsor Location: Hong Kong

Study: An exploratory, open-label, single arm study to assess the effect of local application patch on blood circulation

Status: Study Start up Phase

Health Condition: Stem Cells Therapy in Type II Diabetes Mellitus

Sponsor Location: India

Study: An open-label, single arm, prospective study to evaluate the safety and efficacy of Allogenic stem cell transplantation as an adjunct to exogenous insulin therapy in patients with type ii diabetes mellitus

Status: On Hold

Health Condition: NA (Healthy Volunteers)

Sponsor Location: United States

Study: Assessment of the effect of herbal supplement on the levels of circulating endothelial progenitor cells and hematopoietic stem cells in human subjects

Status: Study Start up Phase

60M NutrAssist Program

Product Development Process has always been a challenge for innovator companies. With stiff market competition and stricter regulations dietary supplement or nutraceutical companies always want to be fully sure that their product development plan is in accordance to the regulatory requirements of the land. Myriad costs crop up from the word go in the product development process. Some companies would resort to seek the right consultant to guide them in understanding and following regulations. Finding such an expert in the supplement industry is not only time-consuming but come with their own cost structures. This is a compelling reason for companies to shy away from such consulting firms. A lack of direction and no proper guidance often leads to a break in the product development process. To combat such irregularities and challenges, Vedic offers a unique opportunity to all supplement manufacturing/marketing companies who want to make sure that the path chosen by their organization is going to optimally help the product positioning into the markets.

Presenting 60M NutrAssist Program, the 60 minutes FREE consultation given by Vedic Lifesciences Product Development Experts.

FDA enforcement: An injunction for disease claims

An Oregon herb and supplement manufacturer has been slapped with a permanent injunction for disease claims on products. 

Claim substantiation is one of the major concerns in the successful clinical development of a nutraceutical/ dietary product. It is a critical component in the process as false or misleading claims made by supplement manufacturers are subjected to judicial action. Often manufacturers find themselves at crossroads due to their lack of knowledge of correct label claims. They prefer to set these claims by relying on information which most of the times may come in from dubious sources and try to avoid consultants who are experts in the field. Result; Product Recall or in the above case a permanent injunction. How do you avoid such a situation? First and foremost one needs to identify the product correctly in accordance to the therapeutic benefits accrued from its ingredients. An overzealous effort to claim what doesn’t exist or relate to certain health conditions can even cause fatalities. Specific Claims need substantiation and cannot be stated without clinical evidence. Consult a right consultant with experience and expertise in the field of Nutra product research. Such consultants will guide you in understanding your product potential and will assist you in drawing up correct and relevant claims and then substantiate the same. Vedic offers a simple and scientific environment to substantiate your claims. Let us help you deliver your promise of good health.

http://www.nutraingredients-usa.com/Regulation/FDA-enforcement-Consent-decree-for-GMP-violations-and-an-injunction-for-disease-claims

ACElerator: Client - CRO Model

                                                                                              

Conduct of clinical trials has always been a challenge for the Natural Product industry with regards to cost and data credibility.  As a result many companies prefer not to invest their resources in R&D activities at all. To tackle such issues and instill confidence in our clients, Vedic Lifesciences offers a unique Client – CRO model for all Claim Substantiation Human Studies – ACElerator.

Under ACElerator, we share the project responsibilities with you and train your in- house team in areas like site selections, monitoring, data management and data capture. We would support with clinical study documentation, statistical analysis and report writing. With your trained team we will generate reliable human data for your products at a substantially reduced cost. This data can be presented or published in a high impact factor, peer reviewed journal. An additional benefit of this program is the creation of in-house research capabilities in your companies for future clinical trials.

Nutra/Dietary supplement/Traditional Medicine companies looking to increase their brand value or expanding their product line in new geographies without significant R&D investments can make optimum use of Vedic Lifesciences’ new ACElerator model.

To know more, click here

Industry News

The health care industry is a critical com­ponent of economies worldwide. As economic meltdown begins drug/supplement companies are trending towards shelving early-stage projects and working on late phase development. In a shaky economy, demand from clients is slack. As these companies move to rationalize their pipelines, CRO's are competing for fewer projects and RnD dollars while trying to achieve the same scale as in years past. A slump in early phase development is not bad news. Contract research organizations begin to engage in preferred partnership and strategic alliances to combat the Big R – ‘Recession’